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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K252420
Device Name Wearable Breast Pump (Model W12)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Pa
Rk, #21 Bulan Rd., Xialilang Community, Nanwanstreet, Lon
Shenzhen,  CN 518100
Applicant Contact Dale Wang
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Pa
Rk, #21 Bulan Rd., Xialilang Community, Nanwanstreet, Lon
Shenzhen,  CN 518100
Correspondent Contact Dale Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/01/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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